A Beneficial Metabolic Effect of Daily Dosing of Tadalafil 5mg in Type 2 Diabetic Patients with Erectile Dysfunction; A randomized, double-blinded, placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005666

Enrollment

Registered

2020-12-09

Start date

2017-01-04

Completion date

Unknown

Last updated

2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : In a Randomized, Double-blind, Placebo-Controlled study, all patients were randomized (2:1 ratio) to receive 5 mg/d tadalafil or placebo, and instructed to take one dose of study medication at

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) 75 aged 30-75 years male persons who had a regular sexual partner and had an intercourse once or more for the last one month 2) Type 2 diabetic men with ED 3) Newly diagnosed DM (HbA1c; 6.5~9%, or FBS > 126 ) 4) No history of taking PDE5 inhibitors within the last 1 months

Exclusion criteria

Exclusion criteria: 1) Contraindications for PDE5 inhibitors 2) Malignant tumors within the last 6 months 3) Prior or current use of thiazolidinediones, nitratest in any form (e.g., nitroglycerin, isosorbide dinitrate, nitroprusside, and others), alpha-blocking drugs (doxazosin, terazosin , or prazosin), protease inhibitors (ritonavir and others) 4) Change in dose of metformin within the last 3 months

Design outcomes

Primary

Measure	Time frame
gycated hemoglobin A1c;glucose, insulin, c-peptide, insulin sensitivity (HOMA-IR) ß cell function (HOMA-ß), Body mass index, waist circumference, and lipid profile	—

Secondary

Measure	Time frame
BUN, Creatinine, ALT, AST, Hemoglobin	—

Countries

Korea, Republic of

Contacts

Public ContactMin-Kyung Lee

Myongji Hospital

Outcome results